Actively Recruiting
MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.
Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-06-19
60
Participants Needed
1
Research Sites
621 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase II trial of a reduced intensity conditioned (RIC) allogeneic hematopoietic cell transplant (HCT) with post-transplant cyclophosphamide (PTCy) for idiopathic severe aplastic anemia (SAA), paroxysmal nocturnal hemoglobinuria (PNH), acquired pure red cell aplasia (aPRCA), or acquired amegakaryocytic thrombocytopenia (aAT) utilizing population pharmacokinetic (popPK)-guided individual dosing of pre-transplant conditioning and differential dosing of low dose total body irradiation based on age, presence of myelodysplasia and/or clonal hematopoiesis.
CONDITIONS
Official Title
MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic severe aplastic anemia with refractory cytopenia or early myelodysplastic features or post-transplant graft failure requiring second transplant
- Diagnosis of paroxysmal nocturnal hemoglobinuria, acquired pure red cell aplasia, or acquired amegakaryocytic thrombocytopenia with refractory cytopenia, early myelodysplastic features, or post-transplant graft failure requiring second transplant
- Adequate organ function within 30 days before conditioning
- Age from birth to 75 years
You will not qualify if you...
- Pregnant, breastfeeding, or intending to become pregnant during the study without a negative pregnancy test within 7 days before treatment
- Uncontrolled infection
- Moderate or severe portal fibrosis or cirrhosis confirmed by biopsy
- Known allergy to any study drugs or components
- Prior radiation therapy considered excessive for low dose total body irradiation
- Diagnosis of inherited bone marrow failure disorders unless approved by investigator
- Advanced myelodysplastic syndrome or acute myeloid leukemia
- Psychiatric or social conditions limiting study compliance
- Other medical issues that would exclude participation per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
C
Christen Ebens, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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